Medtronic MiniMed 670G System Recalled for Loose Insulin Reservoir
Medtronic is recalling MiniMed 670G Systems with SmartGuard because a broken or missing retainer ring can cause the insulin reservoir to become loose, leading to incorrect insulin delivery.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device that can lead to hypoglycemia or hyperglycemia, which are significant health risks. The source text notes reported incidents of the defect but does not explicitly state that injuries or illnesses have resulted, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic Inc. is recalling the Medtronic MiniMed 670G System with SmartGuard. The recall affects specific model numbers, including MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762, MMT-1580, MMT-1581, MMT-1582, MMT-1780, MMT-1781, and MMT-1782. The devices are identified by all serial numbers, excluding those with black retainer rings. The product was distributed in the United States and various international locations.
The recall is due to reported incidents where the insulin reservoir becomes loose and can no longer be locked into the pump. This issue occurs when the retainer ring is broken or missing, preventing a proper lock. If the reservoir is not properly locked, it may result in the over-delivery or under-delivery of insulin. This malfunction can lead to hypoglycemia (low blood sugar) or hyperglycemia (high blood sugar).
Consumers should contact Medtronic for instructions on how to address the issue. The source text does not specify the number of affected units or the exact number of reported incidents.
The recalled product
- Product
- Medtronic MiniMed 670G System with SmartGuard, Ref #s/Model Number(s) - MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762, MMT-1580, MMT-1581, MMT-1582, MMT-1780, MMT-1781, and MMT-1782
- Manufacturer
- Medtronic Inc.
- Category
- Medical Device — Insulin Pump
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Serial Numbers ( excluding devices with black retainer rings)
Distribution
Part of a larger recall action
This product is one of 4 recalled by Medtronic Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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